OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER
FDA 510(k) clearance K871827 · decided 1987-06-19
Clearance details
- K-number
- K871827
- Device name
- OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1987-05-11
- Decision date
- 1987-06-19
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- KXJ
- Device class
- 2
- Regulation number
- 892.1980
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| APOLLO (K050190) | Villa Sistemi Medicali S.P.A. | 2005-03-25 |
| RADIOGRAPHIC ITT TABLE (K963905) | X-Ray Technologies, Inc. | 1996-11-12 |
| XRT 400 (K955414) | Wuestec Medical, Inc. | 1996-07-24 |
| IMAGING TABLE (K951146) | Septa Corp. | 1995-05-04 |
| CARBON FIBER COUCH INSERT (K950068) | Medtec, Inc. | 1995-04-06 |
| INFRARED EXPOSURE HAND SWITCH (K950442) | Medical X-Ray Intl., Inc. | 1995-03-31 |
| SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 (K940696) | Philips Medical Systems North America, Inc. | 1994-03-16 |
| ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES (K931724) | Continental X-Ray Corp. | 1993-06-14 |
| MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM (K926407) | Nucletron-Oldelft Corp. | 1993-03-31 |
| CAG-02A (K922098) | Toshiba America Medical Systems, In.C | 1992-07-27 |
| OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 (K913121) | Continental X-Ray Corp. | 1991-08-16 |
| RADKOR, RF-159 (K883885) | Radkor, Inc. | 1988-10-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017) | General Electric Co. | 1988-07-29 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013) | General Electric Co. | 1988-07-15 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016) | General Electric Co. | 1988-06-30 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014) | General Electric Co. | 1988-05-05 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015) | General Electric Co. | 1988-05-02 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012) | General Electric Co. | 1987-11-25 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011) | General Electric Co. | 1987-06-18 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010) | General Electric Co. | 1987-03-30 |